BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI AVANTI+ 6F STD W/GW NO OBT

    MDR report key: 8657953 · Received May 31, 2019

    Report

    Report Number
    9616099-2019-02985
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 2, 2019
    Report Date
    July 18, 2019
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DRE
    UDI-DI
    10705032010054
    PMA / PMN Number
    K970392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS RECEIVED FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    DURING A TRANSCATHETER AORTIC VALVE INTERVENTION (TAVI) PROCEDURE, PART OF THE 6F AVANTI SHEATH (STD W/GW NO OBT) SEPARATED IN THE PATIENT AND THE PIECE OF THE SHEATH COULD NOT BE RETRIEVED. THE PATIENT WAS SENT TO SURGERY TO SUCCESSFULLY RETRIEVE THE SEPARATE PIECE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL OR DAMAGES NOTED ABOUT THE SHEATH PRIOR TO USE. THERE WAS NO DIFFICULTY ENCOUNTERED DURING INSERTION. AFTER POSITIONING THE INTRODUCER, IT IS REPLACED BY ONE WITH A LARGER DIAMETER, BUT DURING REMOVAL, THE INTRODUCER DOES NOT RETRACT. AFTER APPLYING GREATER FORCE, THE DEVICE BROKE AND PARTS OF THE SHEATH WAS LEFT IN THE ARTERY. ATTEMPTS WERE MADE TO RECOVER THE PIECES BUT IT WAS IMPOSSIBLE. THE PIECES WERE RECOVERED WITH SURGICAL ACCESS. THE PROCEDURE WAS THEN PERFORMED WITHOUT FURTHER COMPLICATIONS. A NON-STERILE CANNULA SEGMENT OF PRODUCT CSI ¿SI AVANTI+ 6F STD W/GW NO OBT¿ WAS RECEIVED INSIDE OF A CLEAR PLASTIC BAG. PART WAS REMOVE FROM THE PLASTIC BAG TO DO A FIRST VISUAL INSPECTION WITHOUT ANY OPTICAL MAGNIFYING DEVICE. THE DEVICE WAS BLOOD-SATURATED. A SEPARATED CONDITION ON THE CANNULA WAS OBSERVED LOCATED AT 10 CM FROM THE DISTAL TIP. SEVERAL DAMAGES WERE OBSERVED ON THE LENGTH OF THE CANNULA. NO OTHER ANOMALIES WERE OBSERVED. THE TWO SEGMENTS WERE PLACED UNDER THE MICROSCOPE IN ORDER TO OBTAIN A MAGNIFIED IMAGE OF THE SEPARATED AREA. THE END OF THE SEPARATED SECTIONS PRESENTED EVIDENCE OF ELONGATIONS AND FRAYED EDGES; ALSO SHOWED TWISTING CONDITIONS. THESE CHARACTERISTICS SUGGEST THAT THE DEVICE WAS INDUCED TO STRETCHING/PULLING OR TWISTING EVENTS THAT EXCEED THE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. NO OTHER ISSUES WERE NOTED DURING MICROSCOPIC ANALYSIS. DIMENSIONAL ANALYSIS WAS PERFORMED TO VERIFY THE CORRECT CANNULA ID AND THE CORRECT OD, THE MEASUREMENTS WERE TAKEN AS CLOSE AS POSSIBLE TO THE DAMAGES, AND RESULTS FOR THE CSI CANNULA WERE FOUND WITHIN SPECIFICATION. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17823950 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED ¿CATHETER SHEATH INTRODUCER - SEPARATED IN PATIENT¿ WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. HOWEVER, THE EXACT CAUSE OF THE SEPARATION COULD NOT BE DETERMINED DURING ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND PRODUCT ANALYSIS, PROCEDURAL/HANDLING FACTORS (AFTER APPLYING GREATER FOR, THE SHEATH BROKE) MOST LIKELY CONTRIBUTED TO THE SEPARATION REPORTED AS EVIDENCED BY THE EVIDENCE OF ELONGATIONS, FRAYED EDGES, AND TWISTING CONDITION. THESE CHARACTERISTICS SUGGEST THAT THE DEVICE WAS INDUCED TO STRETCHING/PULLING OR TWISTING EVENTS THAT EXCEEDED THE MATERIAL¿S YIELD STRENGTH PRIOR TO THE SEPARATION. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿IF INCREASED RESISTANCE IS FELT UPON INSERTION OF THE CSI, INVESTIGATE THE CAUSE BEFORE CONTINUING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED AND CORRECTED, DISCONTINUE THE PROCEDURE AND WITHDRAW THE CSI. THREAD THE CSI/DILATOR ASSEMBLY OVER THE GUIDEWIRE, GRASPING THE SHEATH CLOSE TO THE SKIN TO PREVENT BUCKLING. USING A ROTATING MOTION, ADVANCE THE ASSEMBLY THROUGH THE TISSUE AND INTO THE VESSEL.¿ CONTROLS ARE IN PLACE TO VERIFY THE DEVICE CONDITIONS; THE PRODUCED CSI ARE INSPECTED 100% BEFORE LEAVING THE FACILITY. NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A TRANSCATHETER AORTIC VALVE INTERVENTION , PART OF THE AVANTI SHEATH SEPARATED IN THE PATIENT AND THE PIECE OF THE SHEATH COULD NOT BE RETRIEVED. THE PATIENT WAS SENT TO SURGERY TO SUCCESSFULLY RETRIEVE THE SEPARATE PIECE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL OR DAMAGES NOTED ABOUT THE SHEATH PRIOR TO USE. THERE WAS NO DIFFICULTY ENCOUNTERED DURING INSERTION. AFTER POSITIONING THE INTRODUCER, IT IS REPLACED BY ONE WITH A LARGER DIAMETER, BUT DURING REMOVAL, THE INTRODUCER DOES NOT RETRACT. AFTER APPLYING GREATER FORCE, THE DEVICE BROKE AND PARTS OF THE SHEATH WAS LEFT IN THE ARTERY. ATTEMPTS WERE MADE TO RECOVER THE PIECES BUT IT WAS IMPOSSIBLE. THE PIECES WERE RECOVERED WITH SURGICAL ACCESS. THE PROCEDURE WAS THEN PERFORMED WITHOUT FURTHER COMPLICATIONS. LOCAL QRA COMMENT: THE CAH CUSTOMER WHO REPORTED THE ISSUE IS A COMPANY RESELLING CORDIS PRODUCTS TO SOME HOSPITALS IN (B)(6) (ACCOUNT NAME: (B)(6)). THE ACCOUNT NUMBER SPECIFIED WITHIN THE CIF IS ASSOCIATED WITH (B)(6) AS THERE IS NO ACCOUNT NUMBER AVAILABLE SPECIFICALLY FOR THE ACTUAL HOSPITAL WHERE THE EVENT OCCURRED ((B)(6)). HOWEVER, THE ACCOUNT NAME WITHIN THE CIF HAS BEEN CHANGED TO PROVIDE CORDIS WITH THE NAME OF ACTUAL HOSPITAL WHERE THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451760 SI AVANTI+ 6F STD W/GW NO OBT DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION 504606X 17823950 10705032010054

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention